RESOR-PIN RESORBABLE MEMBRANE PIN

K972817 · Geistlich-Pharma · LYC · Jul 24, 1998 · Dental

Device Facts

• Record ID: K972817
• Device Name: RESOR-PIN RESORBABLE MEMBRANE PIN
• Applicant: Geistlich-Pharma
• Product Code: LYC · Dental
• Decision Date: Jul 24, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Resor-Pin is used in oral, dental and maxillofacial surgery and guided bone regeneration.

Device Story

Resor-Pin is a resorbable membrane pin used in oral, dental, and maxillofacial surgery. It functions as a fixation device to secure membranes during guided bone regeneration procedures. The device is intended for use by dental or maxillofacial surgeons in a clinical setting. By providing stable fixation for membranes, it facilitates bone regeneration in surgical sites. The device is designed to be resorbed by the body over time, eliminating the need for a secondary removal procedure.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Resorbable membrane pin for surgical fixation. Material properties allow for degradation over time. Device is intended for sterile surgical application.

Indications for Use

Indicated for use in oral, dental, and maxillofacial surgery and guided bone regeneration procedures.

Regulatory Classification

Identification

Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.

Special Controls

*Classification.* (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JU 24 1998

Geistlich-Pharma C/O Mr. Peter S. Reichertz Attorneys at Law Arent Fox Kintner and Kahn, PLLC 1050 Connecticut Avenue, NW Washington, DC 20036-5339

K972817 Re : Resor-Pin Resorbable Membrane Pin Trade Name: Regulatory Class: Unclassified Product Code: LYC Dated: July 8, 1998 Received: July 9, 1998

Dear Mr. Reichertz:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general The general controls controls provisions of the Act. provisions of the Act include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਦੇ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Reichertz

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Whetstone

iy A. Ulatowski Timot Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure a se se se se se se se se

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7 510(k) Nunber (if known):

Device Name Resor-Pin Resorbable Membrane Pin

Indications For Use:

: -

Resor-Pin is used in oral, dental and maxillofacial aurgery Resor-Pin 18 used in oral, doncal and maximulation and guided bone regeneration.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <div>(Division Sign-Off)</div> <div>Division of Dental, Infection Control,</div> <div>and General Hospital Devices</div> |
|---------------|--------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K9712817 |

| Prescription Use (Per 21 CFR 801.109) | X | OR | Over-The-Counter Use |
|---------------------------------------|---|----|----------------------|
|---------------------------------------|---|----|----------------------|

(Optional Formst 1-2-96)